Adverse effects of voriconazole: analysis of the French Pharmacovigilance Database. Export

@article{citeulike:3446093, abstract = {BACKGROUND: The most common adverse effects of voriconazole reported during clinical trials were disturbances of vision (30\% of pts.), skin rashes (17.3\%), and elevations in hepatic enzymes level (approximately 10\% of pts.; varying with enzymes). However, postmarketing data concerning safety of voriconazole are limited. OBJECTIVE: To describe voriconazole adverse drug effects (ADEs) after 4 years of the drug's availability in France and determine their occurrence. METHODS: All cases of ADEs including voriconazole reported to the French Pharmacovigilance Database between 2002 and 2005 were analyzed. For each case, the following data were recorded: age, sex, indication, concomitant disease, concomitant medications, and ADE description. Causality link between voriconazole and ADEs was performed using the Naranjo probability scale. RESULTS: A total of 227 ADE cases were reported in 178 adults and 9 children (<12 y), with 66\% occurring in males. The patients' median age was 49.6 (2-80) years. ADEs included liver function test abnormalities (23\%), visual disturbances (18\%), skin rashes (17\%), neurologic disturbances (14\%), cardiovascular events (10\%), hematologic disorders (8\%), and renal disturbances (4\%). Other less commonly identified ADEs included headache, nausea, vomiting, and diarrhea. Drug-drug interactions were observed in 7 cases. According to the Naranjo criteria, 84\% of ADEs were classified as possible, 7\% as probable, 5\% as highly probable, and 4\% as doubtful. CONCLUSIONS: Most ADEs found in this study are well documented in the literature, except for cardiac complications, which are rarely reported. Few ADEs related to drug interactions were observed; however, due to the extensive metabolism of voriconazole by cytochrome P450 isoenzymes, clinicians should be aware of potential interactions between voriconazole and other drugs metabolized through this pathway.}, author = {Eiden, C. and Peyri\`{e}re, H. and Cociglio, M. and Djezzar, S. and Hansel, S. and Blayac, J. P. and Hillaire-Buys, D. and {}}, citeulike-article-id = {3446093}, citeulike-linkout-0 = {http://dx.doi.org/10.1345/aph.1H671}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/17456542}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=17456542}, doi = {10.1345/aph.1H671}, issn = {1542-6270}, journal = {The Annals of pharmacotherapy}, keywords = {hansel, voriconazole}, month = {May}, number = {5}, pages = {755--763}, posted-at = {2008-10-24 09:33:10}, priority = {2}, title = {Adverse effects of voriconazole: analysis of the French Pharmacovigilance Database.}, url = {http://dx.doi.org/10.1345/aph.1H671}, volume = {41}, year = {2007} }

TY - JOUR ID - citeulike:3446093 L3 - citeulike-article-id:3446093 N2 - BACKGROUND: The most common adverse effects of voriconazole reported during clinical trials were disturbances of vision (30% of pts.), skin rashes (17.3%), and elevations in hepatic enzymes level (approximately 10% of pts.; varying with enzymes). However, postmarketing data concerning safety of voriconazole are limited. OBJECTIVE: To describe voriconazole adverse drug effects (ADEs) after 4 years of the drug's availability in France and determine their occurrence. METHODS: All cases of ADEs including voriconazole reported to the French Pharmacovigilance Database between 2002 and 2005 were analyzed. For each case, the following data were recorded: age, sex, indication, concomitant disease, concomitant medications, and ADE description. Causality link between voriconazole and ADEs was performed using the Naranjo probability scale. RESULTS: A total of 227 ADE cases were reported in 178 adults and 9 children (<12 y), with 66% occurring in males. The patients' median age was 49.6 (2-80) years. ADEs included liver function test abnormalities (23%), visual disturbances (18%), skin rashes (17%), neurologic disturbances (14%), cardiovascular events (10%), hematologic disorders (8%), and renal disturbances (4%). Other less commonly identified ADEs included headache, nausea, vomiting, and diarrhea. Drug-drug interactions were observed in 7 cases. According to the Naranjo criteria, 84% of ADEs were classified as possible, 7% as probable, 5% as highly probable, and 4% as doubtful. CONCLUSIONS: Most ADEs found in this study are well documented in the literature, except for cardiac complications, which are rarely reported. Few ADEs related to drug interactions were observed; however, due to the extensive metabolism of voriconazole by cytochrome P450 isoenzymes, clinicians should be aware of potential interactions between voriconazole and other drugs metabolized through this pathway. IS - 5 JF - The Annals of pharmacotherapy SN - 1542-6270 EP - 763 TI - Adverse effects of voriconazole: analysis of the French Pharmacovigilance Database. VL - 41 SP - 755 KW - hansel KW - voriconazole AU - Eiden, C AU - Peyrière, H AU - Cociglio, M AU - Djezzar, S AU - Hansel, S AU - Blayac, JP AU - Hillaire-Buys, D PY - 2007/05// UR - http://dx.doi.org/10.1345/aph.1H671 ER -